In the United States alone, over 40,000 women die from breast cancer each year, and more than 230,000 new cases are diagnosed; and there are approximately 430 deaths and 2,000 new cases expected for men. Additionally, there are more than 2.8 million breast cancer survivors in the United States, many of who have undergone reconstructive surgery. Approximately 36% of patients with early-stage diagnoses and 60% of patients with late-stage diagnoses undergo mastectomies. Moreover, immediate breast reconstruction following mastectomies has become more common, from 20.8% in 1998 to 37.8% in 2008. This increasing trend is not surprising as breast reconstruction likely provides psychological benefits for women who undergo mastectomies. There is evidence to suggest that nipple and areola reconstruction affects psychological wellbeing by enhancing body image and self-esteem or decreasing the feeling of distress felt by female patients with mastectomies. Evidence also suggests that women are more comfortable with getting a mastectomy if the nipple can be spared during the mastectomy procedure or if nipple reconstruction is possible, if a nipple-sparing mastectomy is not an option. Currently, there are 180,000 mastectomies performed each year in the United States, with roughly 52,000 women receiving immediate reconstruction following mastectomy. However, immediate breast reconstruction with autologous tissue rarely involves nipple reconstruction and nipple reconstruction typically occurs after the initial reconstruction of the breast.
Surgeons have spent decades developing surgical techniques in the hope of improved solutions to nipple reconstruction. The S flap, for example, was reported in 1988 (Cronin et al., Plast. Reconstr. Surg. 81:783 (1988)). Current strategies for nipple and areola reconstruction are limited to surgical techniques that create a nipple structure from existing local tissue, secondary site grafting, 3D tattooing, or using commercially available acellular dermal matrix sheets, such as AlloDerm® or Glyaderm®. Commonly used surgical techniques to reconstruct a nipple, along with tattooing when desired to add pigmentation, include: nipple reconstruction with areola tattoo, nipple and areola reconstruction with tattoo, nipple reconstruction with skin graft to areola, double opposing tab nipple reconstruction, and C-V Flap nipple reconstruction.
Despite the decades of efforts, satisfactory surgical solutions to maintaining nipple projection following nipple reconstruction has remained a difficult problem. For example, in 2002, Shestak et al. reported using three different techniques, the bell flap, the modified star flap, and the skate flap, to reconstruct nipples on patients and then following the patients to determine whether nipple projection was maintained over time. Patients treated with the bell flap procedure lost so much nipple projection after six months that the authors recommended against using it in virtually any patient. Shestak et al., Plast. Reconstr. Surg. 110(3):780-6 (2002).
Surgical methods in general have proved less than ideal because nipple and areola reconstruction are highly dependent on surgical technique and existing tissue. Multiple tattooing sessions are required to achieve the optimal coloration, and tattoo can fade to 40% over time. Double opposing tab nipple reconstruction often leads to necrosis of tissue and faulty nipple reconstruction. C-V Flap nipple reconstruction has to be done during the breast reconstruction. To date, no surgical technique has emerged as fully satisfactory. Further, no tissue engineering strategies have been reported that successfully reconstruct the nipple and areola.
There exists a need for a more naturally aesthetic architecture for nipple and areola reconstruction. Surprisingly, the inventive methods and grafts fill this and other needs.